MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORTRAK ENTERAL ACCESS SYSTEM; DH CORTRAK (EAS)

Model Number	20-0950
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Hypoxia (1918); Pneumothorax (2012)
Date of Event	05/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Avanos medical inc.Received a single report that referenced two different incidences, which were associated with separate units, involving two different patients.This is the second of two reports.Refer to 3011270181-2025-00023 for the first report it was reported, lung placement with cortrak unit.¿the patient was alert and oriented and showed no signs of coughing/ shortness of breath (sob) until oxygen saturations started to drop.The two trained cortrak rns stated after the procedure that they were having difficulty with the device.They stated that every time they tried to advance the tube, the green dot would not move.The green dot stayed positioned at the top of the screen "bouncing" as if it was coiling in the throat.They pulled back and attempted to advance several times, as the tube did not ever appear to move.When the tube tracing did move, it moved very quickly, not in association with their "advancing" and appeared both times, spontaneously in what appeared to be the lower lung.They removed the tube both times and called for assistance.The patient developed a pneumothorax and needed a chest tube.The patient did recover.No death.Discharged to rehab.Cortrak 2 eas is running new software.There was a significant lag from the tube moving to the tracing on the device.No out-of-range message was displayed.¿ patient was not intubated at time of placement, no atypical anatomy reported.No implanted medical devices with electromagnetic interference.No comorbidities.Left lung pneumothorax treated with chest tube.This tube was never placed into the stomach and used.Incident discovered due to patient becoming symptomatic.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation however; device tracings have been returned for review.A review of the device history record is not possible as no lot number was provided; therefore, the udi-pi is unavailable.All information reasonably known as of (b)(6) 2025 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.
Additional Manufacturer Narrative
Additional information: d4 and d10.Software version: v2.8.The sample is reportedly available for this complaint but was not returned when this report was filed.All information reasonably known as of 23-dec-2025 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.
Additional Manufacturer Narrative
The returned cortrak 2 eas (monitor unit (b)(6) and receiver unit (b)(6)) underwent a comprehensive minnetronix service evaluation.The reported failure to trace during placement could not be replicated.Initial and repeated placement testing, including testing with the returned interconnect cable, passed.The interconnect cable connection at the receiver was found loose and was re-tightened.The receiver unit was received with a cracked top enclosure, which was replaced.Calibration, functional testing, and final inspection were completed successfully, and the system met all functional acceptance criteria.The device history records and available service records for the supplied serial numbers were reviewed.No relevant manufacturing or servicing deviations, nonconformances, or abnormal conditions were identified.All applicable acceptance, release, and service criteria were met, and the available service evaluation did not confirm the reported delayed tracing issue root cause could not be determined.All information reasonably known as of 30 jun 2026 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint comp-ghc-25-02471.This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.

• Brand Name: CORTRAK ENTERAL ACCESS SYSTEM
• Common Device Name: DH CORTRAK (EAS)
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): MINNETRONIX, INC.; 1635 energy park dr.; saint paul MN 55108
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 22461976
• Report Number: 3011270181-2025-00024
• Device Sequence Number: 7951159
• Product Code: KNT
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K220588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 20-0950
• Device Catalogue Number: 20-0950
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 08/13/2025; 06/10/2026
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 12/23/2025; 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RU 23030452; RU 23030452
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 226 LB